[Surrogate end points for clinical trials on chronic kidney disease and research of Chinese medicine].
Chronic kidney disease is a kind of disease with the condition always worsening over time passing through a sequence of stages, and the evaluation on its clinical treatment is mainly by observing the speed of renal function deteriorating and the time of terminal renal failure occurrence. In order to conduct the trial go on wheels, the authors proposed that the "surrogate end points (SEP)" should be introduced. It is the biologic mark for substitute the clinical terminal point (event), formed depending upon the scientific evidences of epidemiology, pathophysiology, drug-therapy and other scientific evidence, which could be used for predicting the efficacy or damage of a certain measure, present or absent. This article aimed to explain the definition of SEP and to discuss the usable SEP for clinical trial on chronic kidney disease, such as proteinuria, declination of glomerular filtration rate and its slope coefficient as well as the time of terminal occurrence. Moreover, through analyzing the existent problems in clinical researches concerning TCM treatment of chronic kidney disease, the authors suggested that some improvements, chiefly the utilization of SEP for efficacy evaluation, are necessary in the clinical observation methodologies for chronic kidney disease.
Rao
Xiang-rong
XR
Department of Nephropathy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053. raoyisheng@163.com
Wang
Li
L
Dai
Xi-wen
XW
D000818:Animals; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000592:standards*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate; D006801:Humans; D007676:Kidney Failure, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D007677:Kidney Function Tests; D008516:Medicine, Chinese Traditional
D004365:Drugs, Chinese Herbal